J&J’s Cerenovus Launched Next-Gen Stroke Revascularization Catheter

On February 7, 2024, Johnson & Johnson MedTech’s Cerenovus announced the launch of its next-generation CereGlide 71 intermediate catheter with TruCourse indicated for the revascularization of patients suffering from acute ischemic stroke. 

It expands the portfolio of Cerenovus Stroke Solutions by joining the CereGlide family of catheters, which the business plans to launch. According to the business, the system has been tuned for both the delivery of compatible stent retrievers and for efficient direct aspiration. This contains the neurovasculature’s EmboTrap III revascularization device.

To improve the system’s versatility, Cerenovus added TruCourse technology to it. Even in difficult anatomical situations, it was made to provide doctors with better navigation and access to clots. According to the company, it offers thrombectomy treatments with maximum compatibility, lasting delivery, and dependable traceability.

The next stage of a real-world register will incorporate CereGlide 71, which is currently offered for sale in the United States, according to Cerenovus. The CERENOVUS EXCELLENT Registry is dedicated to the mechanical thrombectomy excision of blood clots that cause strokes.

“CereGlide 71 intermediate catheter is specifically designed to glide through challenging anatomical conditions,” mentioned Mark Dickinson, worldwide president, of Cerenovus. Mark added, “Developed through robust research and clinical insights, our team designed a catheter for physicians that addresses unmet clinical needs by providing reliable trackability, durable delivery, and the versatility for both direct aspiration and stent-retriever use – even in the most challenging anatomical conditions.”

According to DelveInsight’s “Acute Ischemic Stroke Market” report, the global acute ischemic stroke market is estimated to grow at a CAGR of 7.38% during the forecast period from 2023 to 2028. The factors including a growing preference for minimally invasive procedures, an aging population, technological improvements, and growing healthcare costs along with a rise in the cases of acute ischemic stroke are anticipated to propel the acute ischemic stroke market as a whole. 

Dexcom Launched New ONE+ CGM System in Europe 

On February 6, 2024, Dexcom, a San Diego-based company, announced the launch of its latest continuous glucose monitor (CGM) system, the Dexcom ONE+.

After making the system available in Spain, Belgium, and Poland, the company is planning to launch Dexcom ONE+ in the Netherlands, next week. The system is going to replace the previous-generation Dexcom One sensor in some countries,

Utilizing Dexcom’s well-established sensor design, ONE+ was developed by the firm taking user and healthcare professional feedback into account. According to the manufacturer, this guarantees that patients managing type 1 or type 2 diabetes with insulin will have a simple, very successful CGM experience.

The most recent iteration of the platform makes use of the G7 sensor, whereas the G6 was employed in the earlier iteration. Last month, CEO Kevin Sayer stated to Drug Delivery Business News that he anticipated finishing this transition in the first quarter of 2024.

As per DelveInsight’s “Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market valued at USD 13.06 billion in 2022, growing at a CAGR of 7.72% during the forecast period from 2023 to 2028, to reach USD 20.40 billion by 2028. The escalating demand for blood glucose monitoring systems is predominantly attributed to the increasing prevalence of diabetes among the population across the globe and the growing burden of the geriatric population who are susceptible to developing hyperglycemia.

In addition, the spike in technologically advanced blood glucose monitoring devices product launch and government initiatives to raise awareness regarding proper diabetes management, among others are the factors likely to spur the global blood glucose monitoring systems market.

Philips Received the US FDA Nod for Latest Intellivue Patient Monitor Software Including Sounds Alarm Package 

On February 6, 2024, Philips received the US Food and Drug Administration (FDA) 510(k) clearance for its latest IntelliVue patient monitor software.

The Philips Sounds alarm bundle is one of the new solutions offered by the most recent IntelliVue technology. With this permission, the alarm bundle is now available in the United States and over 200 other countries.

Philips brought a fresh viewpoint to acute patient monitor alerts by collaborating with medical professionals and audio specialists. The company sought to round out and soften warning tones in collaboration with SenSound, a sound design agency. Additionally, by utilizing calminger alarm tones to suggest action or more subtly indicate status, it attempted to modify alert intervals. 

IntelliVue reduces the alarm noise by up to 66%, improving the patient and caregiver experience. 

“While alarms in acute care settings must be effective, they should be sensible, informative, and respectful of the surrounding environment and the people in it,” said Christoph Pedain, business leader, Hospital Patient Monitoring, Philips. Christoph mentioned, “Throughout the process, we asked for input from care providers, administrators, patients, and their families who are exposed to these alarms regularly and leveraged powerful data to help improve the experience overall.”

According to DelveInsight’s “Patient Monitoring Devices Market” report, the global patient monitoring devices market was valued at USD 35.21 billion in 2022, growing at a CAGR of 8.20% during the forecast period from 2023 to 2028, to reach USD 56.46 billion by 2028. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders.

Moreover, the sudden outbreak of the COVID-19 pandemic has also contributed to the patient monitoring devices market. Additionally, the growing preferences for remote patient monitoring systems among patients and healthcare providers, the increase in technological advancement in the product arena, and the rise in the approval of various patient monitoring devices in the current year, among others are also some of the factors responsible for potentially increasing the global patient monitoring devices market in the upcoming years.

Toku Obtained CE and UKCA Marks for AI Cardiovascular Risk Assessments Through the Eye

On February 5, 2024, Toku, Inc., a commercial medical device company specializing in AI assessment of retinal images, announced that it has obtained CE and UKCA Marks for its patented CLAiR technology. 

Using retinal images taken during a standard eye exam, CLAiR offers a precise, economical, non-invasive assessment of the risk of cardiovascular disease (CVD) at the point of treatment.

The only area of the vascular system that can be easily and non-invasively photographed is the retina, which is found in the rear of the eye. The CLAiR technology is easily integrated with current retinal cameras, enabling real-time assessments of cardiovascular disease risk that are as accurate as gold standard examinations, which can take weeks and usually involve blood tests. Through the analysis of minute changes in the retina and its vasculature, the AI-powered CLAiR technology determines elevated cardiovascular risk. The patient’s primary care physician might use the CLAiR results to advise preventative measures by starting a thorough cardiovascular evaluation.

Healthcare providers in various settings can accurately identify elevated cardiovascular risk in adult patients with no known history of cardiovascular disease, through CLAiR. 

“I believe that a retinal image can be considered the ‘fifth vital’ along with temperature, heart rate, respiration rate, and blood pressure,” commented Toku CEO Associate Professor Ehsan Vaghefi. Ehsan added further, “The CE and UKCA marks allow us to bring CLAiR to patients across multiple geographies. In my vision of the future, a retinal image analysis is an integral part of a comprehensive screening for major diseases such as cardiovascular or kidney disease.”

Professor John Marshall, the holder of the original patents for refractive surgery and Emeritus Professor of Ophthalmology at both University College London & Kings College, London mentioned, “The eye is the only organ of the body where we can non-invasively view and image blood vessels. The advent of artificial intelligence has enabled the analysis of retinal images to predict the occurrence and time course of numerous diseases of the vascular system, including heart attacks and strokes. Such early risk identification allows timely modification of lifestyle and even earlier treatment to prevent or delay onset. Toku’s CLAiR algorithm is a breakthrough in the field of cardiovascular diseases and should result in lifesaving interventions and improved quality of life for innumerable individuals throughout the world.”

According to DelveInsight’s “Cardiac Monitoring Devices Market” report, the global cardiac monitoring devices market will grow at a CAGR of 5.4% during the forecast period from 2023 to 2028. The demand for cardiac monitoring devices is primarily being boosted by the rising prevalence of cardiovascular diseases, technological advancements in product development, increasing geriatric population, sedentary lifestyle, and increasing awareness programs regarding cardiovascular health.

Genesis MedTech Completed Enrollment in TAVR Trial 

On February 5, 2024, Genesis MedTech announced that the company had completed enrollment in its US early feasibility study for its J-Valve transfemoral TAVR system.

J-Valve developed by JC Medical, the US-based Genesis subsidiary, holds FDA breakthrough device designation for the treatment of severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease.

Patients who have a high risk for surgical aortic valve replacement are eligible for the valve. Eliminating the need for open-heart procedures or extracorporeal circulation, the procedure takes place through a minimally invasive, transfemoral approach.

The design of J-Valve can potentially help treat aortic valve regurgitation, as mentioned by the company. 

The patients for Genesis MedTech’s FDA-approved early feasibility study were enrolled at five centers in the US. The study aims to evaluate symptomatic individuals with severe AR. 

Later this year, the company plans to present data on patients who received treatment with J-Valve. J-Valve remains investigational in the U.S. and Canada.

“This accomplishment would not have been possible without the dedicated efforts of the investigators and research teams involved,” said Dr. Mark A. Turco, CEO of JC Medical and president of vascular intervention North America at Genesis MedTech. Dr. Marck commented further, “We look forward to the data and learnings as well as the initiation of our upcoming Pivotal Trial.” 

According to DelveInsight’s “Transcatheter Aortic Valve Replacement Devices Market” report, the global transcatheter aortic valve replacement devices market was valued at USD 3.23 billion in 2022, growing at a CAGR of 15.41% during the forecast period from 2023 to 2028 to reach USD 7.64 billion by 2028. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation and the technological advancements pertaining to the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market in the upcoming years. 

First Patient Enrolled in Carthera’s Ultrasound Drug Delivery Trial 

On February 5, 2024, Paris, France-based Carthera announced that it enrolled the first patient in the SONOBIRD pivotal trial for its SonoCloud device.

SonoCloud has been designed by Carthera to treat a wide range of brain disorders. By temporarily increasing the permeability of brain blood arteries by ultrasonic emission, the gadget enhances the transport of therapeutic molecules.

SonoCloud activates once it is inserted into the skull before a therapeutic agent is injected. The blood-brain barrier (BBB) is opened for six hours by a few minutes of low-intensity ultrasound, which raises the concentration of therapeutic molecules in the brain.

According to DelveInsight’s “Drug Delivery Devices Market” report, the global drug delivery devices market is growing at a CAGR of 7.90% during the forecast period from 2023 to 2028. The demand for drug-delivery devices is primarily being boosted by the rising number of patients suffering from diabetes, the rising prevalence of cancer patients, the increasing frequency of both chronic and acute diseases, the rising growth of biologics, the increasing technological advancements associated with the drug delivery devices will help in contributing in the overall market growth of the drug delivery devices during the forecast period from 2023-2028.